UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002480 |
|---|---|
| Receipt number | R000002406 |
| Scientific Title | A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications |
| Date of disclosure of the study information | 2009/09/15 |
| Last modified on | 2016/02/10 11:31:12 |
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Basic information
Public title
A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications
Acronym
A randomized controlled trial to reducing wound complications
Scientific Title
A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications
Scientific Title:Acronym
A randomized controlled trial to reducing wound complications
Region
| Japan |
Condition
Condition
Surgery for gastrointestinal diseases
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effect of dermal skin closure on reducing wound complication compared to staple skin closure in gastrointestinal surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Occurrence of wound complications
Key secondary outcomes
Occurrence of keloid formation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
stapling skin-closure
Interventions/Control_2
dermal skin-closure
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) gastrointestinal surgery
2)
4,000/mm3=<WBC=<12,000 /mm3
Hb>=9.0 g/dL
Plt>=100,000 / mm3
T.Bil=<1.5 mg/dL
AST=<100 IU/L
ALT=<100 IU/L
Creatinin=<1.2 mg/dL
Albumin>=2.8 g/dL
3) written informed consent.
Key exclusion criteria
1) emergency
2) laparoscopic surgery
3) re-laparotomy
4) severe infections
5) bleeding tendency or coagulation disorders
6) uncontrolled diabetes mellitus
7) phsychic disorder
8) severe heart or lung diseases
9) continuous use of steroids
Target sample size
1060
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimasa Tsujinaka |
Organization
Osaka National Hospital
Division name
Surgery
Zip code
Address
2-1-14, Hoenzaka, Osaka City, Osaka , JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University
Division name
Gastroentrological Surgery
Zip code
Address
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka
Institute
Department
Personal name
Funding Source
Organization
Multicenter Clinical Study Group of Osaka
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Lancet. 2013 Sep 28;382(9898):1105-12.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 11 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002406
